INVEGA(TM) Shows Favorable Long-Term Safety Profile in a One-Year Study of Patients With Sch...( TITUSVILLE N.J. Dec. 12 /- INVEGA...),Health

TITUSVILLE, N.J., Dec. 12 /PRNewswire/ -- INVEGA(TM) (paliperidone) Extended-Release Tablets showed favorable long-term safety and tolerability during a one-year open-label extension (OLE) study, according to a new, company-sponsored study. In addition, patient symptom scores improved or were stable, on average, over this 52-week study.(1)

The study was designed to evaluate the long-term safety of INVEGA, an oral, atypical anti-psychotic approved for the treatment of schizophrenia. Discontinuations due to treatment-emergent adverse events (TEAEs) and the total number of serious TEAEs were both six percent. Other assessments such as cardiovascular, metabolic and weight-related assessments showed either no mean change or clinically minimal change as a result of the treatment. Symptoms of schizophrenia were reduced during long-term open-label treatment in those patients that transitioned from placebo to INVEGA and were maintained in those that were previously on INVEGA as assessed by the Positive and Negative Symptoms of Schizophrenia (PANSS(a)) scores.

"This long-term extension trial adds to the body of knowledge regarding the safety of INVEGA in the longer-term treatment of schizophrenia. The study also suggests that symptom control is maintained over time," said George M. Simpson, MD, Professor of Research, Director Outpatient Clinic, Keck School of Medicine of the University of Southern California. Dr. Simpson is a principal investigator of the study and a consultant to its sponsors Ortho-McNeil Janssen Scientific Affairs, LLC, Johnson & Johnson Pharmaceutical Research & Development, LLC, and Janssen, L.P., the company that markets INVEGA.

The study consisted of 235 patients (154 male; 81 female) who had participated in the prior double-blind (DB) recurrence prevention study. This study demonstrated a significantly longer time to relapse in patients treated with INVEGA compared with those who received placebo and had been brought to an e
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